NCT05871346

Brief Summary

Appropriate complementary feeding practices as per the World Health Organization recommendations is a window of opportunity to promote health and prevent acute and chronic undernutrition (stunting, wasting \& underweight). Globally, the burden of undernutrition remains unacceptably high, and the progress of undernutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child undernutrition is a major public health problem.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
776

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 7, 2023

Last Update Submit

April 15, 2025

Conditions

Keywords

Complementary feeding counseling (CFC)Appropriate complementary feeding practices (ACFP)Child Undernutrition

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in appropriate complementary feeding practices of mothers for their children at 9 months.

    Questions related to complementary feeding practices will be used to measure these practices of mothers for their children (Appropriate/Inappropriate). To measure appropriate complementary feeding practices, we will follow the World Health Organization recommendations for infant and young child feeding practices, continuation of breastfeeding, starting solid, semi-solid or soft foods at 6 months of age, the eight indicators used to calculate the dietary diversity, and the meal frequency will be asked. Minimum dietary diversity, minimum meal frequency, and consumption of egg and/or flesh food will be determined. Appropriate complementary feeding practice is defined if the four indicators: timely introduction of complementary foods, minimum dietary diversity, minimum meal frequency, and consumption of egg and/or flesh food are fulfilled. Otherwise, inappropriate if a child's feeding practices do not fulfill even one of the components of appropriate complementary feeding practices.

    Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).

Secondary Outcomes (1)

  • Change from baseline in child nutritional status at 9 months

    Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).

Study Arms (2)

Complementary Feeding Counseling

EXPERIMENTAL

Complementary feeding counseling to the mother-child pairs, in the intervention clusters, will be given by trained women development army (WDA) team leaders. The intervention process will have two components; training of WDA leaders, and counseling of mothers. Counselors' training will be given centrally by the principal investigator. During counseling, WDA leaders will use a counseling guide, which is prepared in Amharic, the local and the national language. The counseling guide contains seven key messages; complementary feeding: at 6 months, from 6-8 months, from 9-11 months, from 12-23 months, hygiene, breast feeding a sick child greater than 6 months, and signs that require mothers' special care of their children. Starting the children's 6 months of age, participants in the intervention group will receive in group counseling at convenient places, and individual counseling at each mother-child pair's home every month for 9 consecutive months (a total of 9 months follow up).

Behavioral: Complementary feeding counseling

Routine Complementary Feeding Counseling

EXPERIMENTAL

Participants in the control clusters will receive the routine complementary feeding counseling, which is offered by heath extension workers and other health professionals.

Behavioral: Complementary feeding counseling

Interventions

Complementary Feeding Counseling to Improve Appropriate Complementary Feeding Practices and Reduce Child Undernutrition

Complementary Feeding CounselingRoutine Complementary Feeding Counseling

Eligibility Criteria

Age6 Months - 21 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mother-child pairs whose children are 6 months old.
  • Mother-child pairs who reside in the study area for at least 6 months before the survey.
  • Mother-child pairs who have no intention of leaving the study area during the intervention period.

You may not qualify if:

  • Mothers with severe mental illness or who are unable to communicate (e.g., deaf).
  • Mother-child pairs with severe congenital malformations of their children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahir Dar University

Bahir Dar, Amhara Regional State, Ethiopia

Location

Related Publications (1)

  • Michaelsen KF, Grummer-Strawn L, Begin F. Emerging issues in complementary feeding: Global aspects. Matern Child Nutr. 2017 Oct;13 Suppl 2(Suppl 2):e12444. doi: 10.1111/mcn.12444.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Shiferaw Bi Aynalem, MSc

    Bahir Dar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator.

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 23, 2023

Study Start

June 9, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations